Kornimate/medical-research-clean huggingface dataset:
left atrial appendage occlusion study ii

Conditions: Atrial Fibrillation; Stroke

Summary: a pilot, multicentre randomized controlled study of surgical left atrial occlusion (laa) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke. patients will be enrolled and randomized to undergo laa exclusion and aspirin therapy or best medical therapy as per guidelines. main research questions: 1. can successful occlusion of the laa be safely achieved by cut and sew or stapler techniques? 2. in patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (laa) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin?

the number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (af) is stroke. echocardiographic studies suggest that the predominant source of stroke in af is the left atrial appendage (laa). at present, there are no sufficiently powered trials to answer whether removal of the laa can reduce the risk of systemic embolic events. laaos pilot study will recruit 50 participants undergoing open-heart surgery in 5 canadian academic cardiac surgery centers. the study will inform the feasibility of conducting a large rct and will provide information of the efficacy and safety of appendage occlusion technique. from this study we envision a a large international randomized controlled trial (laaos ii) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.

Eligibility criteria:
inclusion criteria: * adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass * a history of ecg-documented atrial fibrillation with prior stroke or tia, or at least two of the following risk factors: * age =\> 65 years * hypertension * diabetes mellitus, or * heart failure/left ventricular ejection fraction \< 50% exclusion criteria: * patients in whom surgical af ablation (maze or otherwise) is planned * planned "off-pump" surgery * planned implantation of a mechanical valve * heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation

Keywords: atrial fibrillation stroke left atrial appendage re-exploration for bleeding
radical radiotherapy by external beam radiation versus radical radiotherapy with temporary iridium implant plus external beam radiation in carcinoma of the prostate

Conditions: Prostate Cancer

Summary: the specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with stage b2 and c prostatic carcinoma. benefit will be assessed in terms of local recurrence, survival, and toxicity.


Eligibility criteria:
inclusion criteria: * all patients must have histologically proven adenocarcinoma of the prostate * the primary tumour should be staged clinically b2 or c as classified by a.j.c. staging system exclusion criteria: * patients requiring transurethral prostatectomy (turp) prior to diagnosis * presence of metastases identified by bone scan, chest x-ray or ct scan of the abdomen and pelvis, or staging lymphadenectomy * karnofsky performance status less than 80 * inadequate laboratory results: i.e. hb \ 13 mmol/litre, creatinine \> 220 mmol/litre * unfit for surgery for other medical reasons * age above 75 years * failure to provide written informed consent

Keywords: prostate cancer iridium implant radiotherapy
proof-of-principle study of tc-6499 in the treatment of constipation predominant irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: study is to assess the effectiveness of tc-6499 in the treatment of constipation predominant ibs patients over a 28-day period.

this is a randomized, double blind, placebo controlled study of a maximum of 24 subjects with constipation predominant irritable bowel syndrome (ibs-c). sixteen subjects will receive active treatment and 8 subjects will receive matching placebo. there will be a 21-day screening phase before 1st study drug administration on day 1.

Eligibility criteria:
inclusion criteria: * men with ibs-c (rome iii) between 18 and 65 years of age, inclusive. * women with ibs-c (rome iii) between 55 and 65 years of age, or 18 to 55 years of age with documentation of non-childbearing potential status (surgical sterilization or one year post last menses with elevated fsh/lv). * all subjects should have a body mass index (bmi) between 18 and 34 kg/m2, inclusive and a body weight of not less than 45 kg.

Keywords: irritable bowel syndrome ibs-c
ultrasound-guided thoracic spinal level identification

Conditions: Thoracic Diseases; Myofascial Pain

Summary: typically, the rhomboid minor muscles rise from the c7-t1 spinous process and run downward to touch the upper inner corner of the scapula, and the rhomboid major muscles rise from the t2-t5 spinous process and run downward to reach the lower middle inner corner of the scapula. in anatomical research articles, it has been reported that the rhomboid muscle's anatomical variations are rare. considering the characteristics of these rhomboid muscles, the investigators planned a study on the utility of rhomboid muscles as a landmark for identifying thoracic spine levels.


Eligibility criteria:
inclusion criteria: * patients undergoing thoracic nerve root block due to herpes zoster, postherpetic neuralgia, complex regional pain syndrome, post traumatic pain syndrome, or compression fracture of vertebra. exclusion criteria: 1. previous t-spine surgery 2. patient refusal 3. coagulopathy 4. generalized infection or localized infection at injection site 5. anatomical abnormality of t-spine 6. allergic reaction to local anesthetics

Keywords: ultrasound guided intervention rhomboid muscle thoracic spine
neuropsychological and behavioral testing in younger patients with cancer

Conditions: Childhood Malignant Neoplasm

Summary: this research trial studies neuropsychological (learning, remembering or thinking) and behavioral outcomes in children and adolescents with cancer by collecting information over time from a series of tests.

primary objectives: i. to institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological/behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points. outline: parent and child participants complete the cog standard neuropsychological and behavioral battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. the battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.

Eligibility criteria:
inclusion criteria: * the patient must be currently be enrolled or plan to be enrolled on a cog therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning * the patient must have receptive and expressive language skills in english, french, or spanish; if a patient meets these criteria but the parent/guardian speaks a language other than english, french, or spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted * all patients and/or their parents or legal guardians must sign a written informed consent * all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met exclusion criteria: * patients with a history of moderate to profound intellectual disability (i.e. intelligence quotient \[iq\] =\< 55) are not eligible for enrollment; please note: children with a prior history of attention deficit hyperactivity disorder (adhd) or a specific learning disability (e.g., dyslexia) are eligible for this study
new day: nutrition, exercise, weight loss, diabetes and you

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: this clinical trial examines whether the addition of individual sessions of a motivational intervention to a state-of-the art behavioral group weight loss intervention for overweight women with type 2 diabetes improves the weight losses and glycemic control outcomes.

the multi-disciplinary behavioral, group-based intervention focuses on dietary and exercise changes, with group meetings over an 18-month period. participants are assessed at 6-month intervals (for a total of 18 months) to examine the impact of the interventions on body weight and blood sugar control (primary outcomes), as well as on blood pressure, cholesterol, quality of life and attitudes (secondary outcomes). all enrolled participants receive group-based weight loss intervention. half the women enrolled also receive several individual sessions of motivational interviewing and the other half of enrolled women receive the same number of individual sessions of health education, which focus on issues relevant to women (e.g., mammography, sleep hygiene, menopause, etc).

Eligibility criteria:
inclusion criteria: * body mass index of 27 - 50 * type 2 diabetes currently treated with oral medications * ability to walk for exercise exclusion criteria: * use of insulin * current pregnancy * presence of debilitating disease, psychotic condition or any other condition that might interfere with participation * failure to complete self monitoring diary for 1 week * plans to move out of the area in the upcoming 18 months

Keywords: obesity treatment non insulin dependent diabetes type 2 diabetes behavioral weight control motivational interviewing motivational enhancement
medina embolization device in neurovascular aneurysm study

Conditions: Intracranial Aneurysm

Summary: a global prospective, multi-center, single-arm, post-market clinical follow-up (pmcf) study conducted to assess the performance of the medina embolization device when used in unruptured and ruptured intracranial aneurysms.


Eligibility criteria:
inclusion criteria: * subject has provided written informed consent using the ethics committee-approved consent form and agrees to comply with protocol requirements * subject is 18- 85 years old * subject has a ruptured or unruptured saccular intra-cranial aneurysm amenable to be treated with the medina embolization device exclusion criteria: * aneurysm is partially thrombosed * aneurysm has been previously treated with surgery or endovascular therapy * subject has had major brain surgery including endovascular procedures within the past 30 days * vessel characteristics (tortuosity, stenosis, morphology) preclude safe endovascular access to the aneurysm * subject is pregnant or breast-feeding or wishes to become pregnant during the length of the study participation * the investigator determines that the validity of the study outcomes may be compromised by the subject's enrollment

Keywords: embolization device medina rupture intracranial aneurysm unrupture intracranial aneurysm
a one-year, randomized, double-blind, placebo-controlled trial of rosiglitazone in non-alcoholic steatohepatitis

Conditions: Non Alcoholic Steatohepatitis

Summary: this study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (nash).

phase one : a double blind randomized placebo controlled trial of rosiglitazone * 64 pts with biopsy proven nash will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year. * after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment primary endpoint: improvement of at least 30% of the histological score of steatosis secondary endpoints: improvement in alt values, in necrosis and inflammation and fibrosis phase ii extension open label trial all participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. a liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in nash patients.

Eligibility criteria:
inclusion criteria: * histologically proven nash with steatosis \>= 20% * increased serum alt exclusion criteria: * bland steatosis * daily alcohol \> 20/30 g (women/men) * any other cause of liver disease * secondary nash including drug-induced steatohepatitis * treatment with insulin or glitazones * cardiac insufficiency * hb \< 10 g/dl

Keywords: steatosis, fibrosis, diabetes, obesity
pulmonary rehabilitation, dyspnoea and emotional cognition in copd

Conditions: COPD; Dyspnea; Rehabilitation; Tobacco Use; Emotional Disturbances

Summary: to evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (copd).to evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (copd).

the aim of the study will be to evaluate the effect of pulmonary rehabilitation on dyspnoea emotional component and on emotional cognition. it will add a better understanding of the mechanisms of pulmonary rehabilitation on dyspnoea. patients with copd will be included before starting a pulmonary rehabilitation and be evaluated with questionnaires (including the multidimensional dyspnea profile, and quality of life questionnaires), emotional cognition (at rest and right after an endurance test, using some short movies sequences and pictures of faces expressing some well defined emotions) and smile production analysis. after having followed a pulmonary rehabilitation, the same evaluation will be realised and results will be compared before and after the intervention.

Eligibility criteria:
inclusion criteria: * copd patients with pulmonary rehabilitation indication, hospitalized in department of pulmonary diseases in la pitié-salpêtrière, paris, france. * age of 40 at least. exclusion criteria: * facial paralysis * neuromuscular disease * contraindication for pulmonary rehabilitation * severe depression syndrom or psychiatric disease * drug use * impaired vision * higher functions disorders (mini mental score examination \< 26) * severe obesity (bmi\>40kg/m²)
photodynamic therapy for glioblastoma multiforme based on metaverse and yellow fluorescence

Conditions: Glioblastoma Multiforme (GBM)

Summary: gbm patients receiving pdt treatment (50 cases，surgery combined with photodynamic therapy) and traditional treatment (50 cases，traditional surgery) in our hospital and partner hospitals were collected. the prognosis was analyzed by comparing with the control group from multiple perspectives such as image evaluation, imaging effect, karnofsky score, median survival time and survival rate.


Eligibility criteria:
inclusion criteria: pathologically confirmed primary focal gbm; recurrent gbm(single or satellite lesions); multiple (multiple germinal centers)gbm. exclusion criteria: * photosensitizer allergy. * severe coagulation disorder. * patients with severe cardiovascular and cerebrovascular diseases, especially patients in the acute stage. * multiple organ failure, end-stage patients. ⑤ pregnant women: photofrin is considered a class c pregnancy risk (toxic, non-teratogenic) drug with non-dialysis properties. non-gbm diagnosis: patients with other types of brain tumors or diseases. 7 do not agree to informed consent: patients who are unwilling to sign informed consent or do not agree to participate in the study.

Keywords: glioblastoma multiforme photodynamic therapy metaverse yellow fluorescence
prospective registry for patients with chest pain in emergency department

Conditions: Chest Pain

Summary: monocentric, prospective registry collection of clinical data of all patients with chest pain in emergency department and follow-up after 30 days

an unselected patient-population with chest pain entering through the emergency department participate in a diagnostic survey where a chest pain algorithm based mainly on risk scores (grace, timi, heart) verifying the diagnostic forecasting power (sensitivity, specificity, negative and positive predictive value) of biomarkers, risk scores and imaging methods for diagnosing of potential life-threatening disease.

Eligibility criteria:
inclusion criteria: * age \>18 years old chest pain written confirmation of participants or legal representative exclusion criteria: * thorax trauma

Keywords: chest pain
effect of pioglitazone on testosterone in eugonadal men with type 2 diabetes mellitus - a pilot study

Conditions: Type 2 Diabetes Mellitus

Summary: to study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

several clinical studies demonstrated that pioglitazone not only improves insulin sensitivity but also decreases plasma androgen concentrations (dheas and androstenedione) in women with polycystic ovary syndrome (pcos) . however the reduction in the androgen levels in pcos is whether secondary to increase in the insulin sensitivity or due to direct effect of thiazolidinediones on steroidogenesis is not known.so far, two human studies have been conducted regarding the effects of rosiglitazone (a thiazolidinedione group of drug) on testosterone level, one in healthy individuals and another was in patients of type 2 diabetes with hypogonadism . but these studies gave equivocal results as the study population were different. hence we plan to study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Eligibility criteria:
inclusion criteria: * hba1c level of 7.5% or less on stable dosages of sulphonylurea (glimepiride 1-6mg/day) and metformin (1-2g/day) for at least six weeks and bmi of 20-30 kg/m2. exclusion criteria: * hepatic impairment, coronary artery disease and or heart failure, renal failure, those who requires insulin therapy or hba1c \>7.5%, presence of macular edema and serum albumin \<3gm/dl.

Keywords: eugonadal, testosterone
a digital intervention (act on vaping app) for vaping cessation in young adult e-cigarette users

Conditions: Nicotine Dependence; Tobacco-Related Carcinoma

Summary: this clinical trial evaluates a smartphone application (app) called acceptance and commitment therapy (act) on vaping for helping young adults quit using electronic cigarettes (e-cigarettes). e-cigarettes pose numerous risks, particularly to youth and young adults. addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. act on vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. the app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. receiving access to the act on vaping app may be effective in helping young adults quit vaping.

outline: participants are randomized to 1 of 2 arms. arm i: participants use the act on vaping app (version a) and receive a text messaging program to motivate and support quitting. participants also receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status. arm ii: participants use the act on vaping app (version b) and receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status. after completion of study intervention, participants are followed up at 3 and 6 months.

Eligibility criteria:
inclusion criteria: * age 18-30 * age of majority (to provide informed consent) in current state/territory of residence * current weekly user of e-cigarette product(s) for the last 30 days * has a smartphone; either an android (running version 12 or higher) or iphone (running ios version 17 or higher, iphone 11 or more recent) * experience downloading and using one or more apps on their smartphone * have a mobile data plan and/or access to wifi to support the use of the act on vaping app * has access to text messaging * has an email address * united states (us) resident, with a us mailing address * willing to complete all study procedures * comfortable reading and writing in english exclusion criteria: * currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatment is allowable during trial participation) * member of the same household as another research participant * currently in prison * google voice number as sole phone number, due to its association with fraudulent study entry attempts * is ineligible per fraud prevention protocol * employees/family of investigator or study center
a study to assess safety and efficacy of odanacatib (mk-0822) in men with osteoporosis (mk-0822-053)

Conditions: Osteoporosis

Summary: the purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (bmd) compared to treatment with placebo. this study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.

the original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (part 2). amendment 1 of the protocol removed the additional 12 month period and the month 36 bmd analysis was deleted.

Eligibility criteria:
inclusion criteria: * is a male between 40 and 95 years of age * has osteoporosis * has anatomy suitable for dual energy x-ray absorptiometry (dxa) scan of the lumbar spine and and hip * is ambulatory exclusion criteria: * is currently on oral bisphosphonates or other treatment for osteoporosis * had previous hip fragility fracture and is a candidate for standard of care therapy * has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months * has had more then one previous vertebral fracture * has been diagnosed with metabolic bone disorder other than osteoporosis * is vitamin d deficient * has a history of renal stones * has active parathyroid disease * has history of thyroid disease not well controlled by medication * is diagnosed with secondary osteoporosis * has a daily calcium intake of \<1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg * has a history of malignancy ≤5 years prior to signing informed consent * has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems